{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-45A",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-45A.json",
  "legislation": "uksi/2004/1031",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004",
  "path": "regulation/45A",
  "kind": "regulation",
  "number": "45A",
  "heading": "Non-investigational medicinal and non-medicinal products",
  "text": "(1) A non-investigational medicinal product shall be manufactured or assembled in accordance with the principles and guidelines for good manufacturing practice which apply under these Regulations or the 2012 Regulations.\n(2) A product which is not a medicinal product but which is used or to be used in a clinical trial, as described in the protocol, must—\n(a) comply with safety standards applicable to that product; and\n(b) be listed in the investigational medicinal product dossier with information about its properties, labelling, manufacture and safety controls, appropriate to the product.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Pt. 6A inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 31"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/regulation/45A",
    "retrieved_at": "2026-10-29T05:28:03.775386+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}